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New analysis from evolocumab cardiovascular outcomes study

News, 30 August 2017

A new analysis from the evolocumab (Repatha) cardiovascular outcomes study (FOURIER) showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease. There was no evidence of a leveling off effect and no new safety concerns were identified in this analysis.

The results were presented at the European Society of Cardiology (ESC) Congress in Barcelona, Spain and simultaneously published in The Lancet.

Robert P. Giugliano from Brigham and Women’s Hospital and Harvard Medical School, Boston and lead author on the analysis, said: “With this analysis, we’ve further demonstrated the safety and efficacy of achieving an LDL-C well below current targets. These findings from the first analysis of a large cohort of patients to achieve such ultra-low LDL-C levels support the use of intensive lipid-lowering therapies, such as the combination of evolocumab and statin therapy, in high-risk patients to safely reduce the risk of another cardiovascular event.”

Approximately 26,000 patients from the Repatha cardiovascular outcomes study were followed for a median of 2.2 years and stratified post-randomisation into five prespecified groups irrespective of treatment allocation based on achieved LDL-C at week four from baseline: <0.5mmol/L (which converts to less than 20 mg/dL), 0.5-<1.3mmol/L, 1.3-<1.8mmol/L, 1.8-<2.6mmol/L, and ≥2.6mmol/L.

Rates for the primary and secondary composite endpoints and cognitive function testing, as well as safety events, including cancer, hemorrhagic stroke, new onset diabetes, cataract, neurocognitive dysfunction and non-cardiovascular death were compared across these five groups.

The analysis demonstrated that there was a highly significant progressive relationship between lower LDL-C and a lower risk of the primary composite endpoint (ptrend<0.0001). A similar progressive reduction in the key secondary composite endpoint, which included heart attack, stroke or cardiovascular death, was also observed across all five groups (p=0.0001 for a monotonic relationship). There was no meaningful difference in the safety profile across the five groups, including the group with the lowest achieved LDL-C level. Lastly, patients were more likely to achieve very low LDL-C levels when treated with Repatha and statin therapy versus statin alone.

Dr Connolly, consultant interventional cardiologist at Birmingham City Hospital, who led the UK arm of the trial, said: “These results really reassure us that when it comes to LDL-Cholesterol there is no treatment floor - we must push high-risk risk patients as low as possible. It’s great to see the analysis of patients who entered FOURIER with a history of stroke achieving similar benefits to the wider coronary disease trial population.”